Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures (FLORA)

Myota GmbH

Status: Completed

Conditions: Pre-diabetes

Treatments: Dietary Supplement: Myota Metabolic Regulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05593926

LH005

Details and patient eligibility

About

This trial will investigate whether a powdered fibre mix helps maintain healthy blood glucose levels in participants with pre-diabetes, where high blood sugar is a risk of diabetes.

Full description

Pre-diabetes is characterised by high blood glucose levels, high plasma cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Dietary fibre consumption has been hypothesised to improve these metabolic parameters through the viscous properties, and the production of short-chain fatty acids (SCFA) in the intestine.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to provide informed consent
• Have a Body Mass Index (BMI) of at least 25 kg/m2
• Men or post menopausal* women aged 18-70
• Identified as pre-diabetic (HbA1c 6.0% (42 mmol/mol) to 6.4% (47 mmol/ mol)) within the previous 12 months
• Baseline HbA1c result within the range 5.8% (40 mmol/mol) - 6.5% (48 mmol/mol)
• Willing to complete in clinic blood tests and a participant trial survey
• Have access to a smartphone or a computer

Exclusion criteria

• Receiving medication to treat Type 1 or Type 2 diabetes in the previous 6 months
• Have a Body Mass Index (BMI) <25 kg/m2 and >45 kg/m2
• Loss of more than 5% body weight in last 3 months
• Current participation in weight loss program or planned in the next 16 weeks
• Steroid use (except for over the counter NSAID's, topical steroids and inhalers)
• Severe hepatic diseases (including chronic persistent hepatitis, liver cirrhosis or the co-occurrence of positive hepatitis B virus surface antigen and abnormal hepatic transaminase (serum concentrations of alanine transaminase or aspartate transaminase >2.5× the upper normal limit))
• Continuous antibiotic use for >3 days within 4 weeks prior to enrolment
• Continuous use of weight-loss drug for within 3 months of study entry

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Intervention

Experimental group

Description:

The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.

Treatment:

Dietary Supplement: Myota Metabolic Regulator

Placebo

No Intervention group

Description:

Placebo will be 2g of powdered cellulose, to be taken daily alongside usual diet for 24 weeks. Placebo will be 2g of powdered cellulose, to be taken daily alongside usual diet for 24 weeks.